Covid-19 in Hematological Malignancies

COVID-19 Infection in Hematological Malignancies Patients Clinical Trial

— EPICOVIDEHA  

Official title:

Epidemiology of COVID-19 Infection in Patients With Hematological Malignancies: A European Haematology Association Survey

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04733729
• Other study ID #: EHA-IDWG
• Status: Recruiting
• Start date: March 1, 2020
• Est. completion date: March 31, 2024

Study information

• Verified date: November 2023
• Source: Sorveglianza Epidemiologica Infezioni Fungine Emopatie Maligne
• Contact: livio pagano, Prof
• Phone: +390630154180
• Email: livio.pagano[@]unicatt.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The overall purpose of this project is to better understand the epidemiology of COVID-19 in patients with hematological malignancies (including hematopoietic stem cell transplant recipients) in the different European Countries. The results obtained will allow us to better know the prevalence of this complication in the different categories of patients with hematological malignancies (HMs). In order to attain the objectives previously described we will develop a multicentre, international, observational, retrospective and prospective study of consecutive cases of COVID-19 among HMs. There will be a clinical follow-up of the patients included in this study to observe the survival rate. Data collected form this study will be evaluated with a descriptive analysis.

Description:

At the moment, few data on the epidemiology of SARS-CoV-2 infection in patients suffering from hematological malignancies are available. However, the COVID-19 pandemic presents unique challenges and opportunities on hematological malignancies. The future trajectory of this pandemic appears to be growing and hematology communities must continue to prepare for its spread In this project, we will implement cooperation between all members of the hematology departments both within the EHA and outside it, in order to evaluate the epidemiological data on the incidence and outcome in patients with hematological malignancies infected with SARS-CoV-2.

We will provide useful information to inform the individualized plan for patients with hematological malignancies.

We aim to evaluate the epidemiology and outcomes of patients with HM infected with COVID-19,estimate the incidence and type of disease, assess the acute and long-term mortality rate and estimate the overall mortality rate of cases.

This is a cohort retrospective/prospective survey. In the retrospective phase of the study, participating centers will retrospectively review episodes of COVID-19 disease that occurred in patients with hematological malignancies identified at their institutions from February 2020 to December 2020. In the prospective phase of the study, the researchers will include episodes of COVID-19 disease from the start of the study through December 31, 2021.

The study population will need to be over 18 with hematological malignancies and SARS-CoV-2 An electronic database with anonymization will be created and available to collect all information with single access for each participating institution. The data collected will be demographic data,epidemiological factors, admission information, COVID-19 disease severity, history of hematological malignancies, disease status with past / current treatments, and 30 days of diagnosis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: March 31, 2024
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Age equal to or greater than 18 years of age.

• History of hematological malignancies (acute leukemias, myelodysplastic syndromes, myeloproliferative neoplasms, lymphomas, myeloma, chronic myeloprolipherative disorders) at any stage/status.

• Active hematological malignancies at any stage/status.

• Diagnosis of hematological malignancy (acute leukemias, myelodysplastic syndromes, myeloproliferative neoplasms, lymphomas, myeloma, chronic myeloprolipherative disorders) at any stage/status.

• SARS-CoV-2 positive test (nasopharyngeal, BAL, fecal), documented by Real-Time Reverse Transcriptase (RT)-PCR Diagnostic Panels.

Exclusion Criteria:

• Hematological diseases, other than hematological malignancies.

• Not tested positive for SARS-CoV-2

• Patients "off therapy" for more than 5 years

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Infection in Hematological Malignancies Patients
• Hematologic Neoplasms
• Infections
• Neoplasms

Locations

Country	Name	City	State
Italy	ASST-Spedali Civili	Brescia
Italy	AOU Policlinico Federico II	Napoli
Italy	Fondazione Policlinico A. Gemelli IRCCS	Rome
Italy	Istituto Nazionale Tumori Regina Elena IFO	Rome
Italy	Osp. di Circolo-Fondazione Macchi	Varese
Italy	AOUI Verona	Verona

Sponsors (2)

Lead Sponsor	Collaborator
Sorveglianza Epidemiologica Infezioni Fungine Emopatie Maligne	European Hematology Association

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Garcia-Suarez J, de la Cruz J, Cedillo A, Llamas P, Duarte R, Jimenez-Yuste V, Hernandez-Rivas JA, Gil-Manso R, Kwon M, Sanchez-Godoy P, Martinez-Barranco P, Colas-Lahuerta B, Herrera P, Benito-Parra L, Alegre A, Velasco A, Matilla A, Alaez-Uson MC, Marto — View Citation

Kuderer NM, Choueiri TK, Shah DP, Shyr Y, Rubinstein SM, Rivera DR, Shete S, Hsu CY, Desai A, de Lima Lopes G Jr, Grivas P, Painter CA, Peters S, Thompson MA, Bakouny Z, Batist G, Bekaii-Saab T, Bilen MA, Bouganim N, Larroya MB, Castellano D, Del Prete SA — View Citation

Passamonti F, Cattaneo C, Arcaini L, Bruna R, Cavo M, Merli F, Angelucci E, Krampera M, Cairoli R, Della Porta MG, Fracchiolla N, Ladetto M, Gambacorti Passerini C, Salvini M, Marchetti M, Lemoli R, Molteni A, Busca A, Cuneo A, Romano A, Giuliani N, Galim — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Epidemiology of COVID-19 infection in patients with hematological malignancies	to evaluate the epidemiology of COVID infection among all hema malignancies patients subgroups	2020 (1 year)

External Links

•   ASH webpage on COVID in hematology
•   COVID-19 in pediatric malignancies